Confidently track and manage population health with comprehensive SARS-CoV-2 diagnostic solutions

Confidently track and manage population health with comprehensive SARS-CoV-2 diagnostic solutions
 
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Why Comprehensive Testing?

Whether detecting acute infections or performing sophisticated contact tracing, understanding and combatting the COVID-19 pandemic requires diagnostic tests that are accurate and scalable. That is why Siemens Healthineers is proud to offer real-time PCR testing and total antibody testing to aid in establishing a full picture of the impact of SARS-CoV-2. We are prepared to support the immediate supply needs of laboratories throughout the U.S.

As a SARS-CoV-2 infection progresses, a patient’s levels of biomarkers, including viral RNA and antibodies, can change significantly. Multiple testing methods are therefore valuable for assessing both patient recovery and population prevalence.

Estimated time intervals and rates of viral detection are based on data from several published reports. Because of variability among studies, estimated time intervals should be considered approximations and the probability of detection of SARS-CoV-2 infection is presented qualitatively.

PCR testing for viral RNA

FTD SARS-CoV-2 Real Time PCR assay1

  • Single-well, dual target assay covering highly conserved regions within ORF1ab and N gene
  • Validated specimen types include nasopharyngeal and oropharyngeal swabs
  • Dual target design reduces inconclusive results and the need for repeat testing
  • In silico analysis using more than 900 sequences shows 100% detection rate2
FTD SARS-CoV-2 Assay
Diagnostic Performance2

Positive Percent Agreement

100% (91.8-100, 95% CI)

Negative Percent Agreement

100% (88.7-100, 95% CI)

Serology testing for antibodies

SARS-CoV-2 Total Antibody Serology assay1

  • ≥96.5% Positive Predictive Value in in low prevalence populations for accurate patient results3
  • Detect both IgM and IgG antibodies to aid in confirming exposure to COVID-19
  • Test with 100% sensitivity4 to minimize false negatives
  • Smart selection of the S1RBD antigen provides 99.8% specificity to minimize false positives 

SARS-CoV-2 IgG Antibody Serology assay1

  • Aid in diagnosis and monitor the level of immune response over time
  • Help assess the antibody levels of at-risk patients and frontline healthcare workers
  • Meet testing needs for seroprevalence studies
  • Provide actionable results for your clinicians

Learn more about SARS-CoV-2 antibody testing

SARS-CoV-2 Testing Instrument Program

Siemens Healthineers is committed to making high performance SARS-CoV-2 testing solutions accessible for all laboratories. Our SARS-CoV-2 Testing Instrument program provides easy access for customers in need of a new analyzer platform to adopt the highly accurate SARS-CoV-2 PCR and serology assays from our portfolio.

Atellica® IM Immunoassay Analyzers

  • Run up to 440 tests per hour5
  • SARS-CoV-2 Total and IgG Antibody assays now available

Dimension® EXL™ Integrated Chemistry System

  • Run up to 440 photometric, 187 IMT, and 167 immunoassay tests per hour5
  • Automated daily maintenance and no monthly cleaning procedures
  • SARS-CoV-2 Total Antibody assay now available

Dimension Vista® Integrated Chemistry System

  • Process up to 2000 tests per hour5
  • Capacity for 600-800 samples onboard simultaneously
  • SARS-CoV-2 Total Antibody assay now available

ADVIA Centaur® Immunoassay Analyzers

  • ADVIA Centaur® Immunoassay Analyzers
  • Run up to 240 tests per hour5
  • Automated daily maintenance and no monthly cleaning procedures
  • SARS-CoV-2 Total Antibody assay now available

Discuss comprehensive COVID-19 testing with a Siemens Healthineers expert.

Complete the form to receive more information on COVID-19 testing solutions.



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1These SARS-CoV-2 molecular and serology tests have not been FDA cleared or approved. These tests have been authorized by FDA under an EUA for use by authorized laboratories. The molecular test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The serology tests has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.

2FTD SARS-CoV-2 Instructions for Use

3https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

4≥ 14 days post-PCR test.

5Dependent upon test mix.